progressed/relapsed gastric cancer after TS-1 or TS-1/ platinum compounds chemotherapy
Conditions
Interventions
A:CPT-11(150mg/m2/day,day1) every 2 weeks
B:TXL (80mg/m2, day1,8,15) every 4 weeks
C:TS-1 (80-120mg/day, day1-21), CPT-11(80mg/m2/day, day1,15) every 5 weeks.
D:TS-1 (80-120mg/day, day1pm~day15am), TX
Sponsors
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have not received prior antitumor chemotherapies without S-1 or S-1/CDDP treatment, immunotherapy, or radiotherapy (including local irradiation for pain control) as primary chemotherapy. 2) Patients who had received resistant for prior antitumor chemotherapy with S-1 or S-1/CDDP treatment as primary chemotherapy in whom either (a) or (b) below are diagnosed to be present by the principal investigator of the trial. (a) Advanced gastric cancer in which a new lesion or progression has been observed by diagnostic imaging after TS-1 monotherapy or TS-1/CDDP combination chemotherapy (either therapy for 4weeks or more) as primary chemotherapy for gastric cancer. (b) Recurrence during postoperative chemotherapy by TS-1 monotherapy or within 26 weeks of its completion. 3) Patients in whom at least 2 weeks has passed since the completion of the previous chemotherapy. 4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 1, 2 or less. 5) A predicted life expectancy of at least 3 months. 6) Preservation of major organ function to satisfy the following : leukocyte count of >=4,000 to <12,000 mm3 ; platelet count of >= 100,000/mm3 ; hemoglobin of >=8.0 g/dl ; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of <=100 IU/l *Except that even if the AST or ALT value does not fulfill this criterion, if the value is diagnosed to be attributable to the primary disease, such as liver metastasis, the criterion will be no more than 150 IU/l. ; alkaline phosphatase of <=x2 the upper limit of the normal range (ULN) ; serum bilirubin level of <=1.5 mg/dl ; serum creatinine of <=1.2 mg/dl or creatinine clearance level of >=50ml/min (When available, the actual measurement will be used as the eligibility criterion, but the value obtained by using the Cockcroft-Gault formula can also be used) 7) Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Have a double cancer patient 2) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc. 3) Infectious disease 4) Diarrhea (watery stools) 5) Ascites or pleural effusion 6) History of serious drug hypersensitivity (especially such as cyclosporine preparations, containing polyoxyethylene castor oil [Cremophor EL], or such as [vitamin preparations for injection] containing hydrogenated castor oil. 7) Undergoing treatment with other fluoropyrimidine anticancer agents, fluorocytosine, or atazanavir sulfate. 8) Found to have fresh gastrointestinal bleeding that requires repeated transfusion. 9) With liver cirrhosis or jaundice. 10) Undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment. 11) having heart disease, such as ischemic heart disease or an arrhythmia, severe enough to require treatment. 12) With diabetes that is difficult to control. 13) With central nervous system metastasis 14) Pregnant, breast-feeding, or who wish to undergo artificial insemination 15) Any other patient whom the physician in charge of the study judges to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival time. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the qualitative and quantitative toxicity and reversibility of toxicity of each chemotherapeutic regimen. To estimate antitumor activity. To estimate the progression free survival time. | — |
Countries
Japan
Contacts
Public ContactHiroshi Furukawa
Kinki University Faculty of Medicen Department of surgery
Outcome results
None listed